DESCRIPTION (provided by applicant):
The overall objective of the proposed Competing Continuation is to develop and incorporate into the MiTiHeart LVAD those elements necessary to meet the requirements for FDA IDE application. In support of this goal and based on initial FDA communications, it has been determined that the addition of a validated electronic controller and power supply system to the MiTiHeart LVAD along with additional in vitro and in vivo testing are needed to support the IDE application. The MiTiHeart LVAD, which has been developed under previous SBIR Grants and company funds, is a small non-thrombogenic rotary pump with magnetic levitation and a redundant hydrodynamic thrust bearing system. The current design specifies that all blood-contacting surfaces be manufactured from TI-6AI-4V alloy and coated with an innovative fully hydrogenated diamond like carbon (DLC) coating. A heparinized organic film overcoat is applied to all rotating DLC coated blood-contacting surfaces. The combination of hydrophobic DLC coating and hydrophilic organic coating provides an innovative means to reduce the shear stresses and minimize platelet activation, thereby reducing the potential for hemolysis and thrombosis. The proposed performance tests include in vitro hemolysis tests, in vivo bovine calf animal testing, and in vitro long-term durability tests. All LVAD components will be inspected following each test for indications of thrombus formation or coating degradation and will be modified if necessary before embarking on the next test. The following Specific Aims are planned for the proposed SBIR Competing Continuation program: (1) Develop the controller and power supply system for the MiTiHeart LVAD, (2) Manufacture blood pumps for performance evaluations, (3) Conduct in vitro hemolysis testing, (4) Conduct in vivo animal testing using a bovine calf model, and (5) Perform in vitro performance and durability testing. As a result of this program a reliable and thoroughly characterized LVAD with percutaneous controller and power supply system will be readied for additional preclinical testing required prior to submission of the IDE application. In the commercialization efforts of Phase II, the technology developed under this study will be transferred to MiTiHeart Corporation, a subsidiary MiTi, established to manufacture and market unique blood pumps for use as destination therapy for adult heart failure patients of small to medium frame that are not being served by present pulsatile devices.